Status:
TERMINATED
A Study to Evaluate the Effects of a Marine Lipid Oil Concentrate Formulation on Inflammation
Lead Sponsor:
Supplement Formulators, Inc.
Conditions:
Inflammation
Inflammatory Response
Eligibility:
All Genders
35-75 years
Phase:
NA
Brief Summary
To assess the efficacy and safety of a Marine Lipid Oil Concentrate formulation on inflammatory biomarkers and overall well-being in male and female subjects who are overweight to mildly obese, but ot...
Detailed Description
This is a double-blind randomized, placebo-controlled study to evaluate the effects of a Marine Lipid Oil Concentrate formulation on inflammation.. Each subject will receive a specific dose of the stu...
Eligibility Criteria
Inclusion
- Ambulatory, male or female, 35-75 years of age
- A BMI of 23-34.9
- hs-CRP level of 1-7.5 mg/L
- Generally healthy and having no significant difficulty with digestion or absorption of food
- Has been generally weight stable for the past six months (+/- 6 lbs.)
- Willing and able to give written informed consent
- Clearly understands the procedures and study requirements
- Willing and able to comply with all study procedures, including following the recommendations to maintain their usual diet and regular activity, as per protocol
- Able to communicate, including reading, in English
- Have not taken any nutritional supplements that may contain any of the components of the study product for a minimum of 14 days before Screening/baseline
Exclusion
- Having smoked any cigarette, electronic cigarette, cigar, pipe, or used a recreational drug as well as any product containing cannabidiol (CBD) and tetrahydrocannabinol in the past 30 days.
- Donated blood within 30 days before Screening/baseline
- Inability to provide a venous blood sample
- Participation in another study within 30 days before Screening/baseline
- Being pregnant or planning on becoming pregnant during study participation; or breast feeding
- History of allergy or sensitivity to any component of the study products
- Currently taking a lipid lowering medication or dietary supplement
- Currently taking a medication or dietary supplement specifically for pain or inflammation including curcumin and unwilling to washout (i.e., stop taking) for 14 days before Screening/baseline
- Currently taking or having taken a fish oil, krill oil, omega-3 supplement and omega-3 prescription drugs within the past 3 months before Screening/baseline
- Currently taking or having taken pain medications or anti-inflammatory medication(s) (e.g., aspirin, NSAIDs, Cyclooxygenase-2 (COX-2) inhibitors, and corticosteroids) within 14 days before Screening/baseline or in the judgment of the Study Investigator/Sub-I would not preclude participation in the study
- Having been diagnosed, received medical treatment, or taking medication daily for the following medical condition(s):
- Acute or chronic inflammatory or autoimmune disease (including rheumatoid arthritis, system lupus erythematosus, ankylosing spondylitis, Sjögren's syndrome, polymyalgia rheumatica, inflammatory bowel disease, and psoriatic arthritis)
- Presence of active or recurring clinically significant conditions as follows:
- Diabetes mellitus or other endocrine disease
- Acute infection
- Active periodontal disease
- Cardiovascular disease including heart and blood vessel disease, arrhythmia, heart attack, stroke, or heart valve problem
- Gastrointestinal disease including gallbladder problems, gallstones, or biliary tract obstruction
- Thyroid disease (unless on a stable dose of medication for 3 months before screening and unlikely to change medication or dose during the study)
- Hypertension (unless on a stable dose of medication for 3 months screening and unlikely to change medication or dose during the study)
- Neurologic condition/disease
- Cancer (unless skin cancer other than melanoma which has been treated \> 3 years before Screening/baseline)
- Liver, pancreatic, and kidney disease
- Pulmonary disease
- Blood coagulation disorder or other hematologic disease
- Other condition or medication use that would preclude participation in the study in the judgment of the Investigator/Sub-I
- Currently taking any medications or treatment for a psychiatric disorder (bipolar disorder,manic disorder, schizophrenia, apathetic \[inherited\] disorder), that include antidepressant drugs, including selective serotonin reuptake inhibitors (SSRIs), tricyclic and atypical antidepressants; benzodiazepines; central nervous system (CNS) depressants, dextromethorphan, meperidine, monoamine oxidase inhibitors (MAOIs); pentazocine, phenothiazines, and tramadol. These may preclude participation in the study dependent on the judgment of the Investigator/Sub-I.
- Currently taking or having taken within the 30 days before Screening/baseline any hormone replacement therapy (including dehydroepiandrosterone (DHEA), estrogen, progesterone, or testosterone; except those utilized as a method of birth control and which have been taken for \> 3 months, with no anticipated change for the duration of the study)
- Having had a surgical procedure or having an internal medical device which, in the judgment of the Study Investigator/Sub-I, would preclude participation in the study
- Having abnormal screening laboratory test values including bilirubin \> 2.5 x upper limit of normal (ULN), aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine transaminase (ALT)/serum glutamic-pyruvic transaminase (SGPT) \> 2.5 x ULN, serum creatinine \> 1.5 mg/dL, blood glucose \< 85 mg/dL or \> 110 mg/dL, hs-CRP \< 1.0 mg/L or \> 5 mg/L, or other lab test result(s) that would preclude study participation in the judgement of the Study Investigator/Sub-I
- Having blood pressure readings at Screening/baseline \> 140 systolic or \> 90 diastolic on two consecutive readings unless permitted to proceed to the next visit in the judgment of the Study Investigator/Sub-I
- Currently consumes more than 7 standard alcoholic drinks per week for women and 14 drinks per week for men (a standard alcoholic drink is defined as one bottle/can of beer, one glass of wine, or one ounce of hard liquor)
- Unable or unwilling to avoid consuming grapefruit juice or fresh grapefruit, Seville oranges, and tangelos
- History of known or suspected substance abuse (e.g., alcohol, opiates, benzodiazepines or amphetamines).
- Having any other circumstance that precludes study participation in the judgment of the Study Investigator/Sub-I, including use of other nutritional supplements, which will be evaluated on a case-by-case basis.
Key Trial Info
Start Date :
October 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04269876
Start Date
October 31 2019
End Date
September 30 2021
Last Update
January 13 2023
Active Locations (1)
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1
Lfie Extension Clinical Reseach, Inc.
Fort Lauderdale, Florida, United States, 33308